The following data is part of a premarket notification filed by Nanjing Jusha Display Technology Co., Ltd with the FDA for Jusha-c43 Lcd Monitor.
Device ID | K151972 |
510k Number | K151972 |
Device Name: | JUSHA-C43 LCD Monitor |
Classification | Display, Diagnostic Radiology |
Applicant | Nanjing Jusha Display Technology Co., Ltd 301, Hnazhongmen Street, 8F, No. 1 Nanjing International Service Outsourcing Mansion, Nanjing, CN 210036 |
Contact | Ma Jing |
Correspondent | Ma Jing Nanjing Jusha Display Technology Co., Ltd 301, Hnazhongmen Street, 8F, No. 1 Nanjing International Service Outsourcing Mansion, Nanjing, CN 210036 |
Product Code | PGY |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-07-16 |
Decision Date | 2015-09-10 |